Glimelius 1997.

Methods	RCT: To estimate any gain in quantity and QoL produced by chemotherapy in advanced gastric cancer patients Duration: The study was performed in two phases‐a pilot phase between January 1991 and May 1992 at one hospital followed by a multicentre phase between June 1992 and Feb 1995 Patients in both arms received SC Journal: Annals of Oncology 1997
Participants	Participants: advanced gastric cancer (surgically non‐curable) Median Age (years and range): Chemotherapy group + BSC: 64 (45 to 75) BSC group: 63 (40 to 74) Gender: Male/Female ratio Chemotherapy group: 23/8 BSC group: 22/8. Performance status: KPS < 50.
Interventions	Total N = 61 T1: Chemotherapy (n = 31) (ELF regimen, consisting of 5‐fluorouracil (500 mg/2) leucovorin (350 mg/m2) and etoposide (120 mg/m2), given daily on three consecutive days and repeated every third week), or in older patients with poor performance, a 5‐fluorouracil (500 mg/m2)/leucovorin regimen (60 mg/m2) (FLv) was given on 2 consecutive days every second week + BSC versus T2: BSC (n = 30) (chemotherapy was allowed if supportive measures did not result in palliation)
Outcomes	Overall survival, changes in QOL, objective responses, toxicity T1: Overall survival was longer (median eight versus T2: five months) difference not statistically significant (P = 0.12) After corrections for imbalances in pretreatment characteristics, chemotherapy treatment was, however associated with a survival benefit (P = 0.003) T1: More patients (45% 14/31) had an improved or prolonged high QoL for a minimum period of four months versus T2: (20% 6/30 P < 0.05). A similar difference was seen in the treating physician's evaluation of whether the patient was subjectively improved or continued to do well for at least four months (17/31 55% versus 6/30, 20%, P < 0.01). Quality of life at randomisation (R) and after the first two evaluations (1, 2) after two and four months respectively, in the chemotherapy and the best supportive care groups. Pain T1 at (R) 33b, at (1) 24 at (2) 23 T2 at (R) 18, at (1) 18 at (2) 18 Nausea/vomiting T1 at (R) 22b, at (1) 18 at (2) 14 T2 at (R) 9, at (1) 32 at (2) 13 b refers to a statistically significant difference (P < 0.05) between T1 and T2 groups respectively
Notes	Authors conclusions: Chemotherapy can add to both the quantity and QoL in advanced gastric cancer. The number of patients who benefit from treatment is, however still rather limited. The authors do not advocate the routine use of this treatment in the light of yet limited effects and the costs, but rather consider it to selected patients after realistic and adequate information
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	D ‐ Not used